MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC AIMING ARM FOR SUPRAPATELLAR; NAIL,FIXATION,BONE

Model Number	03.010.441
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported on (b)(6) 2020, during an unknown procedure, while the surgeon was using the aiming arm for suprapatellar for proximal interlocks on an expert tibial nail, the drill missed the locking hole through the targeted guide and hit the nail.The guide and drill were removed by utilizing the perfect circles technique.Surgical delay and procedure outcome are unknown.There was no patient consequence.Concomitant devices reported: cann connections scr f/percutan instruments for nails-ex(part number 03.010.404, lot u261953, quantity 1), insertion handle suprapatellar(part number 03.010.440, lot 180183-101, quantity 1), drill bits: trauma (unknown part number, unknown lot, quantity 1), nails (unknown part number, unknown lot, quantity 1).This report involves one (1) aiming arm for suprapatellar.This is report 1 of 4 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: a product investigation was conducted.Visual inspection: aiming arm for suprapatellar was received at us cq.Upon visual inspection at cq, it is observed that the device shows normal surface wear consistent with the device use which would not contribute to the complaint condition.Functional test: functional testing of the device was performed at cq by tightening the thumb screw into insertion handle through the aiming arm.The thumb screw was inserted properly and tightened insertion handle with aiming arm.Further functional test cannot be performed at cq with the available equipment.The complaint can not be replicated with the returned device.Dimensional inspection (micrometer: om803): dimensional inspection of the received device was performed at cq.The threaded diameter of the shaft of the thumb screw was measured and is within specification as per the relevant drawing.Metric screw threads, thread profile was also reviewed.Document/ specification review: the following drawing(s) was reviewed; aiming arm for suprapatellar threaded shaft asme b1.13m-2005 metric screw threads, thread profile was also reviewed.No design issues or discrepancies were found during this investigation.Investigation conclusion: visual inspection, functional test, dimensional inspection, and document specification review of the received device was performed at cq.The complaint cannot be confirmed as the functional test could not be performed and replicate the complaint condition.A definitive root cause could not be determined for the reported failure.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.A manufacturing related potential cause was not suspected, therefore, per franchise complaint product investigation procedure no manufacturing record evaluation is required device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: AIMING ARM FOR SUPRAPATELLAR
• Common Device Name: NAIL,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9899661
• Report Number: 2939274-2020-01604
• Device Sequence Number: 2818473
• Product Code: JDS
• UDI-Device Identifier: 10886982068835
• UDI-Public: (01)10886982068835
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K111667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.010.441
• Device Catalogue Number: 03.010.441
• Device Lot Number: 170039-202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CANN CONNECTING INSTRUMENTS; INSERTION HANDLE FOR SUPRAPATELLAR; UNK - DRILL BITS: TRAUMA; UNK - NAILS